MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 7 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number 151620705

Device Problem Noise, Audible (3273)

Patient Problems Pain (1994); Synovitis (2094); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 11/05/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint (b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the.

Event Description

Attune claim record received.Claim record alleges severe and persistent pain, discomfort, instability, popping and clicking of her device, difficulty ambulating and loosening of the tibial component at an unknown interface.Unknown cement was used.Doi: (b)(6) 2015.Dor: (b)(6) 2018.Left knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Medical records received were reviewed by a clinician to identify patient harms/product issues.Patient received left primary attune tka to treat severe left knee osteoarthritis.The patella was resurfaced and depuy cement x 3 was utilized.The procedure was completed without complications.Patient received left knee revision due pain and joint instability secondary to tibial tray loosening.Pre-incision passive range of motion (rom) under anesthesia revealed the left knee to be grossly unstable.The surgeon notes the left knee rom was approximately 10 degrees hyperextension and 115 degrees flexion due to limitations caused by the patient¿s large body habitus.Upon entering the joint, the surgeon identified and debrided synovitis.The tibial tray was loosened and completely debonded at the cement to implant interface.There was a substantial medial tibial defect.The femoral component was well-fixed but revised.The patella was well-fixed and retained.There was no reported product problem with the explanted tibial insert.The patient was revised with competitor products.The procedure was completed without complications.

Manufacturer Narrative

Product complaint (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  h10 additional narrative: added: a2 (dob and age), d4 (lot, catalog, expiration date and udi), h6 (no code available (3191) is used to capture the device revision or replacement).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Corrected: g1.

• Brand Name: ATTUNE CR FB INSRT SZ 7 5MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY RAYNHAM A. DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9511203
• MDR Text Key: 185191813
• Report Number: 1818910-2019-124551
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 151620705
• Device Lot Number: 623377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ATTUNE CR FEM LT SZ 7 CEM; ATTUNE FB TIB BASE SZ 7 CEM; ATTUNE MEDIAL DOME PAT 41MM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female